- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288219
Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
September 1, 2020 updated by: N. Stuart Harris MD MFA, Massachusetts General Hospital
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Patients in the Everest area will assessed for evidence of acute HAPE.
Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: N. Stuart Harris, MD, MFA
- Phone Number: 617-724-3290
- Email: nsharris@mgh.harvard.edu
Study Contact Backup
- Name: Blair A Parry
- Phone Number: 617-724-4758
- Email: bparry@mgh.harvard.edu
Study Locations
-
-
-
Kathmandu, Nepal
- Recruiting
- Himalayan Rescue Association
-
Contact:
- Brian Strickland, MD
- Phone Number: +977 1-4440293
- Email: bstrickland@mgh.harvard.edu
-
Sub-Investigator:
- Brian M Strickland, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults (age 18-80)
- Travel through Pheriche, Nepal
- Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound
Exclusion Criteria:
- History of chronic respiratory conditions (asthma, COPD, ILD)
- Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure
- Kidney disease
- Neurologic disorder
- Cognitive disorder
- Temporary altered mental status
- Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE
- Age under 18 or over 80
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care Treatment
Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
|
Nifedipine 30mg, Pharmacotherapy
supplemental oxygen
|
Experimental: Non-Invasive Positive Pressure Ventilation Management
CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
|
Nifedipine 30mg, Pharmacotherapy
Continuous positive airway pressure delivered by face mask at 10cmH2O
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen saturation
Time Frame: Up to 4 hours
|
Displayed on pulse oximeter
|
Up to 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasonographic assessment of pulmonary edema
Time Frame: Up to 4 hours
|
Quantification of B-lines
|
Up to 4 hours
|
Subjective rating of dyspnea
Time Frame: Up to 4 hours
|
Based on Dypnea Severity Scale (DSS)
|
Up to 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
February 25, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Signs and Symptoms, Respiratory
- Hypertension
- Altitude Sickness
- Hypertension, Pulmonary
- Edema
- Hypoxia
- Pulmonary Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Nifedipine
Other Study ID Numbers
- 2019P003234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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